Regeneron, Sanofi's Dual-Action Biotech Asthma Drug Performs Well In Key Test
Published: Nov 12, 2014
November 11, 2014
By Mark Terry, BioSpace.com Breaking News Staff
Tarrytown, N.Y.-based Regeneron Pharmaceuticals, Inc. , and Paris-based Sanofi jointly announced today the positive results from a recent Phase 2b study of dupilumab for the treatment of asthma. The compound blocks IL-4 and IL-13, two cytokines involved in the immunological component of asthma.
“Many have thought that targeting the Th2 pathway in asthma would limit benefit to a subset of asthmatics, such as those with high eosinophils,” said Elias Zerhouni, president of Global R&D for Sanofi in a statement. “In this study, blocking IL-4/(L-13 signaling with dupilumab improved lung function and reduced severe exacerbations in the broader study population. Based on these results, we plan to move dupilumab into Phase 3 clinical development in patients with moderate-to-severe uncontrolled asthma.”
The study was double-blind, placebo-controlled and lasted 24 weeks. It enrolled 776 adults with moderate-to-severe uncontrolled asthma. The participants were randomized so that they received a placebo or one of four doses of dupilumab. The four dosages were 300 mg every other week, 200 mg every other week, 300 mg monthly and 200 mg monthly.
While participating, patients continued with their medium- or high-dose inhaled corticosteroid and long-acting beta agonist treatment. They also used inhalers with rescue medication as needed. In addition, about 77 percent of the patient had a history of atopic disease—atopic dermatitis, allergic conjunctivitis, allergic rhinitis, chronic rhinosinusitis, nasal polypsis, food allergy and/or hives. About 40 percent of participants had high eosinophils across the dose ranges.
Patients in the study with high eosinophil counts showed mean improvements from the baseline. In the overall population and in both eosinophil patient group and overall patient group there were mean improvements as well as a reduction in adjusted annual rate of severe exacerbations compared to placebo. The most common side effects were reactions at the injection site, upper respiratory tract infections, headache, nasopharyngitis and bronchitis.
“Patients with moderate-to-severe asthma have a high unmet medical need, often struggling with daily symptoms and recurring asthma attacks, despite the use of inhaled steroids, long-acting beta agonists and rescue medications,” said Regeneron Chief Scientific Officer George Yancopoulos in a statement. “This trial is encouraging given the positive results observed on the most clinically meaningful endpoints—FEV1, a key measure of lung function, and asthma exacerbations—were seen on top of ongoing background therapy. We look forward to continued investigation in further studies.”